21st Century Cures Revisions Tell FDA To Highlight ‘Patient Experience Data’
Lame-duck passage is goal of changes to reform legislation, which now includes highly targeted funding for FDA.
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PDUFA Acronym War Begins: Could Reauthorization Be Called Patient-UFA?
For first time ever, the administration that negotiated a user fee agreement won’t be shepherding its reauthorization through Congress.
Patient Advocacy With FDA Review Staff Will Be Tougher Post-Sarepta
Efforts by CDER management to encourage more interaction between patients and FDA reviewers may be part of the collateral damage from the difficult FDA review of Sarepta’s Exondys 51. The hopes of parents of boys with DMD pushed the regulatory flexibility by CDER management on this application – but may end up limiting the willingness of FDA reviewers to engage with patients in the future.
REMS Abuse Legislation: GPhA and PhRMA Set To Battle Again
Senate bill would allow generic companies to bring civil suits against brand sponsors that use REMS requirements to avoid providing samples for testing.